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| ID | Type | Description | Link |
|---|---|---|---|
| P30DK097512 | U.S. NIH Grant/Contract | View source |
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Because this study was initiated during the COVID pandemic, several outcome measures (including those requiring in-person assessments) were abandoned.
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The study design is a prospective observational study in adolescents who are at risk for developing Type 2 Diabetes (T2D), to evaluate the effectiveness of sparkling water to reduce dietary intake of added sugars and thereby improve glycemia. Study data on consumption and the flavor profile of sparkling water will serve as a measure of acceptability. The study intervention will be to provide carbonated flavored sparkling water for 12 weeks to adolescents (and their families) who have a usual intake of 2 or more servings of sugar sweetened beverages (SSB) per day and are at a high risk for developing type 2 diabetes. Study measures will be obtained before and after the exposure to carbonated flavored sparkling water and each participant will serve as his/her own control. To encourage the participants to substitute the carbonated flavored sparkling water, study personnel will send them weekly iMessages through the Technology Assisted Dietary Assessment (TADA) app. In addition, investigators will monitor the participants' diet, using the TADA app, every two weeks, for 4 days. Study measurements will be obtained at baseline, before the intervention, during and at the end of the 12 week intervention.
Objective: Determine the effect of reducing added sugars intake by substituting carbonated sparkling water on T2D risk in adolescents.
Hypothesis: Adolescents who decrease consumption of SSB by substituting sparkling water will experience decreased blood glucose concentrations and increased insulin sensitivity during an oral glucose tolerance test and decreased glucose excursions during continued glucose monitoring, compared to those who do not decrease consumption of SSB.
Importance of studying added sugars in adolescents. Research that leads to nutritional strategies to prevent T2D in adolescents is an urgent pursuit. One particular contributing factor to the growth of T2D and prediabetes in adolescents is the increased consumption of added sugars. Adolescents in the U.S. have high intakes of added sugars which could have poor health implications. Added sugars are found in sugar sweetened beverages and desserts and snacks, top sources of energy for adolescents, and calories from added sugars contribute to 16% of the total energy intake. Levels are well above recommendations from leading scientific organizations, which suggest limiting added sugars to less than 10% of energy. However, it is not clear whether sugar reduction to less than 10% of energy is palatable for an adolescent population that prefers sweetened foods and beverages. Moreover, uncertainty about the evidence linking added sugar consumption to risk of disease has made policies that seek to reduce dietary intake of added sugar controversial. The controversy impairs large-scale implementation of recommendations to reduce intake of added sugars by individuals, clinicians, policy makers and industry stakeholders.
Evidence linking added sugars and risk of type 2 diabetes and cardiovascular disease lacks information on adolescents. Many epidemiological studies in adults, but not all show the concept that after controlling for energy intake, high consumption of sugar-sweetened foods is a risk factor for T2D. Epidemiological studies also associate high consumption of added sugars, particularly from sugar sweetened beverages (SSB), with increased adiposity (including central adiposity) and dyslipidemia. These studies formed the basis of recommendations to limit added sugar consumption from the American Heart Organization. The data in youth is limited. Two small randomized studies compared the effects of glucose versus fructose beverages on insulin sensitivity in adolescents and findings were mixed. One longitudinal cohort study showed that higher consumption of added sugars, from SSB, was associated with hyperglycemia and impaired insulin sensitivity in youth aged 8 - 12 years. One study showed that high amounts of added sugars may induce insulin resistance and beta-cell dysfunction and such effects can occur independent of adiposity. The literature lacks evidence linking high consumption of added sugars to risk of developing youth-onset T2D.
Substituting Flavored Sparkling Water for Sugar Sweetened Beverages. Instead of sugar, food manufacturers typically sweeten foods beverages using low-calorie or artificial sweeteners. "Diet" versions of SSB have been available for several decades and are widely used by adults and children. However the safety of low calorie sweeteners is controversial and many in the scientific and lay communities do not promote their use as a substitute for SSB. We propose that an alternative to SSB may be found in sparkling waters (carbonated water with flavoring, completely unsweetened), which are commercially available in soda-like flavors like cola or Dr. Pepperâ„¢. The rationale for the current project is the urgent need for an effective strategy to combat adolescent T2D which investigators will address by demonstrating the benefit of an intervention to reduce added sugars. The objective of the study is to demonstrate whether substituting sparkling water for SSB has benefits for in vivo physiological measures of glycemia while maintaining flavor acceptability to adolescents who are at risk for diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Replacement of SSB with Unsweetened Sparkling Beverage | Experimental | To encourage participants to substitute sparkling water flavored water for SSB intake, we will provide enough supplies of the drinks to adolescents (and their families) each month. We will also provide iPhones with the TADA app to the adolescent participants. Study staff will remind participants to consume the sparkling water through iMessages sent through the TADA app. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unsweetened flavored sparkling water | Other | Unsweetened sparkling waters are carbonated water with flavoring, completely unsweetened, which are commercially available in soda-like flavors like cola |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dietary Consumption of SSB and Sparkling Water | Dietary consumption of SSB and Sparkling water were assessed using Technology Assisted Dietary Assessment (TADA) system, a mobile food record | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in 2 Hour Glucose Concentrations | Oral glucose tolerance testing will be performed in the morning after participants have undergone an overnight fast for 8 hours at baseline and Week 12. Blood samples will be obtained at -15, 0, 15, 30, 60, 90,120 minutes, relative to ingestion of a glucose drink at a dose of 1.75 g/kg body weight (maximum 75 g glucose). | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Fasting Glucose | Fasting glucose will be measured after overnight fast for 8 hours, just prior to the initiation of the baseline oral glucose tolerance testing at Baseline and Week 12. | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Hemoglobin A1c (HbA1c) Concentration | HbA1c will be measured just prior to the initiation of the oral glucose tolerance testing at baseline and Week 12. | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Whole-body Insulin Sensitivity Index (WBISI) | For measures of insulin action, which takes into account serum glucose and insulin concentrations, serum fractions from the oral glucose tolerance tests will be frozen at -80 degrees C until analysis. The inverse of fasting insulin (1/fasting insulin) will be used as a surrogate estimate of whole-body insulin sensitivity. | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 0% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 0% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception. |
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Inclusion Criteria:
Exclusion Criteria:• Pregnancy
participant eligibility is based on self-representation of gender identity
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| Name | Affiliation | Role |
|---|---|---|
| Nana Gletsu Miller, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University School of Public Health | Bloomington | Indiana | 47405 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31790544 | Background | Andes LJ, Cheng YJ, Rolka DB, Gregg EW, Imperatore G. Prevalence of Prediabetes Among Adolescents and Young Adults in the United States, 2005-2016. JAMA Pediatr. 2020 Feb 1;174(2):e194498. doi: 10.1001/jamapediatrics.2019.4498. Epub 2020 Feb 3. | |
| 26391469 | Background | Banfield EC, Liu Y, Davis JS, Chang S, Frazier-Wood AC. Poor Adherence to US Dietary Guidelines for Children and Adolescents in the National Health and Nutrition Examination Survey Population. J Acad Nutr Diet. 2016 Jan;116(1):21-27. doi: 10.1016/j.jand.2015.08.010. Epub 2015 Sep 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Replacement of SSB With Unsweetened Sparkling Beverage | To encourage participants to substitute sparkling water flavored water for SSB intake, we will provide enough supplies of the drinks to adolescents (and their families) each month. We will also provide iPhones with the TADA app to the adolescent participants. Study staff will remind participants to consume the sparkling water through iMessages sent through the TADA app. Unsweetened flavored sparkling water: Unsweetened sparkling waters are carbonated water with flavoring, completely unsweetened, which are commercially available in soda-like flavors like cola |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Demographic summary of study participants that completed the 12-week intervention
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Replacement of SSB With Unsweetened Sparkling Beverage | To encourage participants to substitute sparkling water flavored water for SSB intake, we will provide enough supplies of the drinks to adolescents (and their families) each month. We will also provide iPhones with the TADA app to the adolescent participants. Study staff will remind participants to consume the sparkling water through iMessages sent through the TADA app. Unsweetened flavored sparkling water: Unsweetened sparkling waters are carbonated water with flavoring, completely unsweetened, which are commercially available in soda-like flavors like cola |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Dietary Consumption of SSB and Sparkling Water | Dietary consumption of SSB and Sparkling water were assessed using Technology Assisted Dietary Assessment (TADA) system, a mobile food record | Because we were unable to complete in-person training due to the COVID pandemic, there was poor adoption of the TADA system during the COVID-19 pandemic, and valid/sufficient data collection was not completed for any of the participants. | Posted | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
|
During the 12 week study
Any change in the health condition of the participants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Replacement of SSB With Unsweetened Sparkling Beverage | To encourage participants to substitute sparkling water flavored water for SSB intake, we will provide enough supplies of the drinks to adolescents (and their families) each month. We will also provide iPhones with the TADA app to the adolescent participants. Study staff will remind participants to consume the sparkling water through iMessages sent through the TADA app. Unsweetened flavored sparkling water: Unsweetened sparkling waters are carbonated water with flavoring, completely unsweetened, which are commercially available in soda-like flavors like cola |
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Because of the Covid-19 pandemic, data were not collected for the following outcomes:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nana Gletsu Miller | Indiana University | 812-8557643 | ngletsum@indiana.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 23, 2020 | Sep 16, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 28, 2024 | Sep 16, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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Prospective, before and after, cohort study
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| Change in Insulinogenic Index (IGI) | For measures of insulin action, which takes into account serum glucose and insulin concentrations, serum fractions from the oral glucose tolerance tests will be frozen at -80 degrees C until analysis. Early phase insulin secretion during the OGTT will be expressed as the insulinogenic index (IGI) or the ratio of the incremental response of insulin to glucose at 30 minutes of the OGTT (IGI30). | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Oral Disposition Index (oDI) | For measures of insulin action, which takes into account serum glucose and insulin concentrations, serum fractions from the oral glucose tolerance tests will be frozen at -80 degrees C until analysis. The oDI will be calculated as IGI30 × 1/fasting insulin. | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Glycemic Control | We will collect free-living, glucose measures for 6 consecutive days using the Continuous Glucose Monitoring (CGM; FreeStyle Libre Pro System; Abbott; Abbott Park, IL). The CGM will be administered to participants 6 days before the start of Week 0 and Week 12, and the monitor will be removed at the clinic visit. For the placement of the CGM, the back of the participant's upper arm will be cleaned with an alcohol wipe and dried. The sensor will be firmly adhered to the arm with the needle application inserted. The FreeStyle sensor measures glucose every 15 sec and records an average glucose value every 15 min for up to 14 days. | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 1.8% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 1.8% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception. | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 2.8% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 2.8% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception. | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 4.4% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 4.4% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception. | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 6.8% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 6.8% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception. | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 10.7% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 10.7% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception. | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 0% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 0% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever". | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 1.8% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 1.8% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever". | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 2.8% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 2.8% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever". | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 4.4% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 4.4% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever". | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 6.8% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 6.8% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever". | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 10.7% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 10.7% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever". | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Blood Triglycerides | Plasma triglyceride concentration will be measured. | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Blood Pressure | Blood pressure will be measured after 5 minutes of rest, on the right arm in the supine position. | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| Change in Waist Circumference | The distance around the waist will be measured. | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
| 20869486 | Background | Reedy J, Krebs-Smith SM. Dietary sources of energy, solid fats, and added sugars among children and adolescents in the United States. J Am Diet Assoc. 2010 Oct;110(10):1477-84. doi: 10.1016/j.jada.2010.07.010. |
| 29342109 | Background | Bailey RL, Fulgoni VL, Cowan AE, Gaine PC. Sources of Added Sugars in Young Children, Adolescents, and Adults with Low and High Intakes of Added Sugars. Nutrients. 2018 Jan 17;10(1):102. doi: 10.3390/nu10010102. |
| 19190645 | Background | Boushey CJ, Kerr DA, Wright J, Lutes KD, Ebert DS, Delp EJ. Use of technology in children's dietary assessment. Eur J Clin Nutr. 2009 Feb;63 Suppl 1(Suppl 1):S50-7. doi: 10.1038/ejcn.2008.65. |
| Background | Running, C.A. Desensitization but not sensitization from commercial chemesthetic beverages. Food Quality and Preference 2018 Vol. 69 Pages 21-27; DOI: 10.1016/j.foodqual.2018.05.001 |
| 24198307 | Background | Wang J, Light K, Henderson M, O'Loughlin J, Mathieu ME, Paradis G, Gray-Donald K. Consumption of added sugars from liquid but not solid sources predicts impaired glucose homeostasis and insulin resistance among youth at risk of obesity. J Nutr. 2014 Jan;144(1):81-6. doi: 10.3945/jn.113.182519. Epub 2013 Nov 6. |
| 10480510 | Background | Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Change in 2 Hour Glucose Concentrations | Oral glucose tolerance testing will be performed in the morning after participants have undergone an overnight fast for 8 hours at baseline and Week 12. Blood samples will be obtained at -15, 0, 15, 30, 60, 90,120 minutes, relative to ingestion of a glucose drink at a dose of 1.75 g/kg body weight (maximum 75 g glucose). | Because of the COVID-19 pandemic, data were not collected for this outcome measure (as in-person assessments were abandoned). | Posted | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
|
|
| Primary | Change in Fasting Glucose | Fasting glucose will be measured after overnight fast for 8 hours, just prior to the initiation of the baseline oral glucose tolerance testing at Baseline and Week 12. | Because of the COVID-19 pandemic, data were not collected for this outcome measure (as in-person assessments were abandoned). | Posted | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
|
|
| Primary | Change in Hemoglobin A1c (HbA1c) Concentration | HbA1c will be measured just prior to the initiation of the oral glucose tolerance testing at baseline and Week 12. | Because of the COVID-19 pandemic, data were not collected for this outcome measure (as in-person assessments were abandoned). | Posted | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
|
|
| Primary | Change in Whole-body Insulin Sensitivity Index (WBISI) | For measures of insulin action, which takes into account serum glucose and insulin concentrations, serum fractions from the oral glucose tolerance tests will be frozen at -80 degrees C until analysis. The inverse of fasting insulin (1/fasting insulin) will be used as a surrogate estimate of whole-body insulin sensitivity. | Because of the COVID-19 pandemic, data were not collected for this outcome measure (as in-person assessments were abandoned). | Posted | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
|
|
| Primary | Change in Insulinogenic Index (IGI) | For measures of insulin action, which takes into account serum glucose and insulin concentrations, serum fractions from the oral glucose tolerance tests will be frozen at -80 degrees C until analysis. Early phase insulin secretion during the OGTT will be expressed as the insulinogenic index (IGI) or the ratio of the incremental response of insulin to glucose at 30 minutes of the OGTT (IGI30). | Because of the COVID-19 pandemic, data were not collected for this outcome measure (as in-person assessments were abandoned). | Posted | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
|
|
| Primary | Change in Oral Disposition Index (oDI) | For measures of insulin action, which takes into account serum glucose and insulin concentrations, serum fractions from the oral glucose tolerance tests will be frozen at -80 degrees C until analysis. The oDI will be calculated as IGI30 × 1/fasting insulin. | Because of the COVID-19 pandemic, data were not collected for this outcome measure (as in-person assessments were abandoned). | Posted | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
|
|
| Primary | Change in Glycemic Control | We will collect free-living, glucose measures for 6 consecutive days using the Continuous Glucose Monitoring (CGM; FreeStyle Libre Pro System; Abbott; Abbott Park, IL). The CGM will be administered to participants 6 days before the start of Week 0 and Week 12, and the monitor will be removed at the clinic visit. For the placement of the CGM, the back of the participant's upper arm will be cleaned with an alcohol wipe and dried. The sensor will be firmly adhered to the arm with the needle application inserted. The FreeStyle sensor measures glucose every 15 sec and records an average glucose value every 15 min for up to 14 days. | Because of the COVID-19 pandemic, data were not collected for this outcome measure (as in-person assessments were abandoned). | Posted | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
|
|
| Secondary | Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 0% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 0% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception. | The analysis population included all participants who completed both the pre- and post-intervention assessments, measured per JAR scale. | Posted | Median | Full Range | score on a scale | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
|
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| Secondary | Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 1.8% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 1.8% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception. | The analysis population included all participants who completed both the pre- and post-intervention assessments, measured per JAR scale. | Posted | Median | Full Range | score on a scale | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
|
|
|
| Secondary | Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 2.8% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 2.8% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception. | The analysis population included all participants who completed both the pre- and post-intervention assessments, measured per JAR scale. | Posted | Median | Full Range | score on a scale | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
|
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| Secondary | Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 4.4% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 4.4% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception. | The analysis population included all participants who completed both the pre- and post-intervention assessments, measured per JAR scale. | Posted | Median | Full Range | score on a scale | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
|
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| Secondary | Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 6.8% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 6.8% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception. | The analysis population included all participants who completed both the pre- and post-intervention assessments, measured per JAR scale. | Posted | Median | Full Range | score on a scale | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
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| Secondary | Change in Flavor Perception of Beverage Sweetness - Tested With a Beverage With Sugar Concentration 10.7% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 10.7% (weight per volume), and rated the beverage using a "Just About Right" (JAR) visual analog scale for sweetness perception. The JAR scale anchors at: -100, "Not sweet enough"; -50, "Slightly not sweet enough"; 0, "Just about right"; +50, "Slightly too sweet"; and +100 "Too sweet." In this scale, the greater the deviation from zero the more suboptimal the perception. | The analysis population included all participants who completed both the pre- and post-intervention assessments, measured per JAR scale. | Posted | Median | Full Range | score on a scale | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
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| Secondary | Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 0% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 0% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever". | The analysis population included all participants who completed both the pre- and post-intervention assessments using the hedonic visual analog scale for liking | Posted | Median | Full Range | score on a scale | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
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| Secondary | Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 1.8% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 1.8% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever". | The analysis population included all participants who completed both the pre- and post-intervention assessments using the hedonic visual analog scale for liking | Posted | Median | Full Range | score on a scale | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
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| Secondary | Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 2.8% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 2.8% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever". | The analysis population included all participants who completed both the pre- and post-intervention assessments using the hedonic visual analog scale for liking | Posted | Median | Full Range | score on a scale | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
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| Secondary | Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 4.4% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 4.4% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever". | The analysis population included all participants who completed both the pre- and post-intervention assessments using the hedonic visual analog scale for liking | Posted | Median | Full Range | score on a scale | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
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| Secondary | Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 6.8% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 6.8% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever". | The analysis population included all participants who completed both the pre- and post-intervention assessments using the hedonic visual analog scale for liking | Posted | Median | Full Range | score on a scale | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
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| Secondary | Change in Hedonic Visual Scale for Liking - Tested With a Beverage With Sugar Concentration 10.7% (Weight Per Volume) | Participants consumed a test beverage with sugar concentration 10.7% (weight per volume) and rated the beverage for liking using a hedonic visual analog scale. This scale anchors at: -100, "Worst ever"; -50, "Dislike"; 0, "Neutral"; +50, "Like"; +100, "Best ever". | The analysis population included all participants who completed both the pre- and post-intervention assessments using the hedonic visual analog scale for liking | Posted | Median | Full Range | score on a scale | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
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| Secondary | Change in Blood Triglycerides | Plasma triglyceride concentration will be measured. | Because of the COVID-19 pandemic, data were not collected for this outcome measure (as in-person assessments were abandoned). | Posted | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
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| Secondary | Change in Blood Pressure | Blood pressure will be measured after 5 minutes of rest, on the right arm in the supine position. | Because of the COVID-19 pandemic, data were not collected for this outcome measure (as in-person assessments were abandoned). | Posted | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
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| Secondary | Change in Waist Circumference | The distance around the waist will be measured. | Because of the COVID-19 pandemic, data were not collected for this outcome measure (as in-person assessments were abandoned). | Posted | Between 0 and 12 weeks (pre-testing was at week 0, post-testing at week 12) |
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| 0 |
| 22 |
| 0 |
| 22 |
| 0 |
| 22 |
Not provided
Not provided
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |